NCT07245446 A Study of Ivonescimab in First-Line ES-SCLC
| NCT ID | NCT07245446 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Akeso |
| Condition | Extensive-stage Small Cell Lung Cancer (ES-SCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-10-29 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 180 participants in total. It began in 2025-10-29 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The main questions the study aims to answer are: * What side effects do participants experience from these combination treatments? * How well do the treatments work to shrink tumors? Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are: * Group 1 will also receive an additional drug called AK117. * Group 2 will also receive a different additional drug called Cadonilimab. * Group 3 will receive Ivonescimab and chemotherapy only. Participants will: * Be assigned by chance to one of the three groups. * Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group. * If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years. * Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * No prior systemic therapy for ES-SCLC. * At least one measurable lesion as defined by RECIST v1.1. * Age 18 to 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed). * History of severe hypersensitivity to monoclonal antibodies. * Active autoimmune disease requiring systemic treatment within the past 2 years. * Significant cardiovascular disease. * Active hepatitis B or C, or HIV infection. * Interstitial lung disease or non-infectious pneumonitis. * Significant bleeding tendency or risk, including tumor invasion of major blood vessels. * Pregnancy or lactation. * Other active malignancies within 5 years prior to enrollment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07245446 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Extensive-stage Small Cell Lung Cancer (ES-SCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07245446 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07245446 currently recruiting?
Yes, NCT07245446 is actively recruiting participants. Contact the research team at wenting01.li@akesobio.com for enrollment information.
Where is the NCT07245446 trial being conducted?
This trial is being conducted at Beijing, China, Xi'an, China, Shanghai, China.
Who is sponsoring the NCT07245446 clinical trial?
NCT07245446 is sponsored by Akeso. The trial plans to enroll 180 participants.
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